COGT

Cogent Biosciences is positioned to commercialize bezuclastinib across three indications, leveraging a single precision molecule for multi-market entry. Positive pivotal data in GIST, NonAdvSM, and AdvSM underpin three NDAs, with regulatory decisions expected between late 2026 and early 2027. COGT's commercial infrastructure and $865.9M liquidity provide a runway through 2028, supporting launch and early commercialization activities.

Cogent Biosciences (COGT) witnesses a hammer chart pattern, indicating support found by the stock after losing some value lately. This coupled with an upward trend in earnings estimate revisions could mean a trend reversal for the stock in the near term.

Submission based on results of APEX pivotal trial which demonstrated bezuclastinib objective response rate (CR+CRh+PR+CI) of 65% per mIWG criteria and 81% ORR per PPR criteria with a well-tolerated safety profile for AdvSM patients

NDA acceptance with Priority Review builds upon previous assignment of Breakthrough Therapy Designation and Real-Time Oncology Review following Phase 3 PEAK results; PDUFA date set for November 30, 2026

WALTHAM, Mass. and BOULDER, Colo.

WALTHAM, Mass. and BOULDER, Colo., May 12, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today announced two presentations from the company's Advanced Systemic Mastocytosis (AdvSM) program, including an oral presentation highlighting the results of the APEX trial, as well as a poster presentation from its emerging JAK2 V617F program at the European Hematology Association (EHA) Congress being held in Stockholm, Sweden, June 11-14, 2026.

- Planning for dual launches of bezuclastinib in Systemic Mastocytosis and Gastrointestinal Stromal Tumors (GIST) - Pivotal data from Phase 3 PEAK trial in GIST patients selected for oral presentation at 2026 ASCO annual meeting  - Ended 1Q 2026 with $866.4 million in cash, sufficient to fund operations into 2028 WALTHAM, Mass. and BOULDER, Colo.

WALTHAM, Mass. and BOULDER, Colo.

– Updated presentation on Cogent's potent pan-KRAS(ON) inhibitor, CGT1263, showcasing its selectivity profile which could lead to reduction in skin toxicity associated with multi-RAS inhibitors